Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Triple Negative Breast Neoplasms

In brief

The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

Key facts

Study ID

NCT04251533

Run by

Novartis Pharmaceuticals

People needed

137

Starts

2020-06-08

Expected to finish

2026-02-05

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC
• Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present. Part B1: Participants must have measurable disease
• Participant has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Participant has received no more than one line of therapy for metastatic disease
• Participant has adequate bone marrow and organ function

You may not qualify if…

• Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
• Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients
• Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia
• Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening
• Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c
• Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion
• Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis
• Participant has currently documented pneumonitis/interstitial lung disease
• Participant has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS)
• Participant with unresolved osteonecrosis of the jaw

Where it is running

• Hematology and Oncology Clinic — Baton Rouge, Louisiana, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Park Nicollet Institute — Saint Louis Park, Minnesota, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Nedlands, Western Australia, Australia
• Novartis Investigative Site — Innsbruck, Tyrol, Austria
• Novartis Investigative Site — Leoben, Austria
• Novartis Investigative Site — Barretos, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Plovdiv, Bulgaria
• Novartis Investigative Site — Hefei, Anhui, China
• Novartis Investigative Site — Shijiazhuang, Hebei, China
• Novartis Investigative Site — Changsha, Hunan, China
• Novartis Investigative Site — Nanjing, Jiangsu, China
• Novartis Investigative Site — Nanchang, Jiangxi, China
• Novartis Investigative Site — Changchun, Jilin, China
• Novartis Investigative Site — Shengyang, Liaoning, China
• Novartis Investigative Site — Shenyang, Liaoning, China
• Novartis Investigative Site — Chengdu, Sichuan, China
• Novartis Investigative Site — Hangzhou, Zhejiang, China
• University of California LA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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